Craig V Comiter1, Eugene Y Rhee2, Le-Mai Tu3, Sender Herschorn4, Victor W Nitti5. 1. Department of Urology, Stanford University Medical School, Stanford, CA. Electronic address: ccomiter@stanford.edu. 2. Department of Urology, Kaiser Permanente Medical Group, San Diego, CA. 3. Department of Urology, Universite de Sherbrooke, Quebec, Canada. 4. Department of Urology, Sunnybrook Health Sciences Center, Toronto, Canada. 5. Department of Urology, New York University Langone Medical Center, New York, NY.
Abstract
OBJECTIVE: To successfully perform male sling surgery, and the surgery must achieve proximal urethral relocation and/or bulbar urethral compression. The Virtue quadratic sling is a novel device that incorporates both mechanisms of action. We report the 1-year results of the Virtue sling with fixation and compare it with the results of the initial "unfixed" sling trial. METHODS: A prospective trial was performed to assess the efficacy and safety of the Virtue sling. Objective success was predefined as >50% decrease in 24-hour pad weight and subjective success as a score of "much" or "very much" better on the Patient Global Impression of Improvement. Subgroups were analyzed by baseline incontinence: mild (<100 g), moderate (100-400 g), and severe (>400 g). After analysis of the 1-year data, a second clinical trial incorporating a novel "fixation" technique was performed, with similar outcome measures. RESULTS: In the initial cohort, subjective and objective successes were achieved in 41.9% at 12 months. Median pad weight reduction was 51.1% at 12 months and varied with the degree of baseline leakage. In the fixation cohort, subjective and objective successes were 70.9% and 79.2%, median pad weight reduction was 88.3% at 12 months, and efficacy was similar regardless of baseline incontinence. There were no cases of prolonged retention and no severe adverse events. CONCLUSION: The Virtue sling with fixation is a safe and efficacious treatment for postprostatectomy incontinence. Superior 12-month results compared with the unfixed device demonstrate that fixation prevents early sling loosening.
OBJECTIVE: To successfully perform male sling surgery, and the surgery must achieve proximal urethral relocation and/or bulbar urethral compression. The Virtue quadratic sling is a novel device that incorporates both mechanisms of action. We report the 1-year results of the Virtue sling with fixation and compare it with the results of the initial "unfixed" sling trial. METHODS: A prospective trial was performed to assess the efficacy and safety of the Virtue sling. Objective success was predefined as >50% decrease in 24-hour pad weight and subjective success as a score of "much" or "very much" better on the Patient Global Impression of Improvement. Subgroups were analyzed by baseline incontinence: mild (<100 g), moderate (100-400 g), and severe (>400 g). After analysis of the 1-year data, a second clinical trial incorporating a novel "fixation" technique was performed, with similar outcome measures. RESULTS: In the initial cohort, subjective and objective successes were achieved in 41.9% at 12 months. Median pad weight reduction was 51.1% at 12 months and varied with the degree of baseline leakage. In the fixation cohort, subjective and objective successes were 70.9% and 79.2%, median pad weight reduction was 88.3% at 12 months, and efficacy was similar regardless of baseline incontinence. There were no cases of prolonged retention and no severe adverse events. CONCLUSION: The Virtue sling with fixation is a safe and efficacious treatment for postprostatectomy incontinence. Superior 12-month results compared with the unfixed device demonstrate that fixation prevents early sling loosening.
Authors: Hanson Zhao; Colby P Souders; Paige K Kuhlmann; Kai Dallas; Karyn Eilber; Jennifer T Anger Journal: Int Neurourol J Date: 2021-05-05 Impact factor: 2.835
Authors: Ireneusz Ostrowski; Emil Śledź; Janusz Ciechan; Tomasz Golabek; Jakub Bukowczan; Mikolaj Przydacz; Tomasz Wiatr; Klaudia Stangel-Wojcikiewicz; Piotr L Chłosta Journal: Cent European J Urol Date: 2015-09-26